Anastomotic leakage is the most dangerous and serious complication of rectal cancer surgery, and is known to occur in 10-20% of surgical patients. Anastomotic leakage causes a long period of hospitalization and a subsequent increase in medical expenses. Moreover, there are advanced research findings that anastomotic leakage may cause long-term rectal dysfunction, and is associated with local tumor recurrence in terms of oncology.
There is currently no appliance which has been clinically verified to be a help to prevent rectal anastomotic leakage. However, some surgeons have used rectal tubes which can be inserted through the anus, with the purpose of protecting anastomoses. Most of these appliances have a long thin tube shape, and are made of a latex material. The rectal tubes are known to protect the anastomotic area through a mechanism in which the pressure of the anal sphincter is lowered to reduce the pressure in the lower rectal canal. However, existing normal rectal tubes are originally devised to assist with enemas for constipation patients, and thus are insufficient in effectively protecting the anastomotic area. Most of all, the technical limitation is that there are no devices capable of effectively filtering or diverting intestinal contents which flow into the anastomotic area.
The present invention is for reducing complications due to the rectal anastomotic leakage after surgery. Until now, the only way to effectively prevent anastomotic leakage was to create an artificial anus (ileal fistula or colorectal fistula). This temporary intestinal fistula protects the anastomotic area from the intestinal contents, and thus is helpful in successively stabilizing the anastomotic area. However, the temporary intestinal fistula has several serious problems, such as its own complications, patient discomfort, complications due to colostomy closure, and additional costs.
Meanwhile, the appliances used to prevent anastomotic leakage are sewed on the anus region using sutures to be fixed to the patient body, which continuously causes the patient's pain after surgery. Thus, the present inventors have invented a separate attachable type fixing device as a less invasive manner in order to alleviate the patient's pain, and the device of the present invention is fixed by being simply attached to the patient's body.
Throughout the entire specification, many papers and patent documents are referenced and their citations are represented. The disclosures of cited papers and patent documents are entirely incorporated by reference into the present specification, and the level of the technical field within which the present invention falls and details of the present invention are explained more clearly.